Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 2:40 AM
Study NCT ID:
NCT04658069
Status:
UNKNOWN
Last Update Posted:
2020-12-08
First Post:
2020-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
T Cell Dysfunction in ESRD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-01', 'studyFirstSubmitDate': '2020-12-01', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death', 'timeFrame': 'January 2021 to December 2023', 'description': 'mortality during the study'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular disease', 'timeFrame': 'January 2021 to December 2023', 'description': 'having documented congestive heart failure, coronary artery disease, peripheral arterial occlusive disease, or stroke'}, {'measure': 'Infection event', 'timeFrame': 'January 2021 to December 2023', 'description': 'having new onset of infections which requiring standard intravenous antibiotics or hospitalization'}, {'measure': 'Cancer', 'timeFrame': 'January 2021 to December 2023', 'description': 'having new discovered tumors'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['T cell dysfunction', 'end-stage renal disease', 'clinical outcome'], 'conditions': ['ESRD', 'T-Cell Dysfunction']}, 'descriptionModule': {'briefSummary': 'Patients with end-stage renal disease (ESRD) suffer from high morbidity and mortality of cardiovascular and infectious disease and increased risk of all-cause mortality which is mainly attributed to the disturbed immune response. More and more evident indicated that T cell dysfunction was universal in ESRD. However, few studies clarified the association of T cell dysfunction and clinical outcomes. This study is aim to explore valuable markers of T cell dysfunction predicting bad clinical outcomes including death, cardiovascular disease, infection and tumor. Hopefully, these finding will provide foundation for further mechanism research and better therapeutic options for ESRD patients in the future.', 'detailedDescription': 'Patients with end-stage renal disease (ESRD) suffer from high morbidity and mortality of cardiovascular and infectious disease and increased risk of all-cause mortality which is mainly attributed to the disturbed immune response. More and more evident indicated that T cell dysfunction was universal in ESRD. Recent evidence suggests uremia-related immune changes resemble to aging immune system, increasing immunological age of T cells by 20-30 years. As compared to an age-matched healthy control, ESRD patients present a lower thymic output of naïve T cells, a decline in the T-cell telomere length and an increase in the differentiation status towards the terminal differentiated memory phenotype with a large number of CD28-negative T cells. More importantly, these changes are strongly associated with a history of cardiovascular diseases and the occurrence of severe infectious episodes in this population, supporting the idea that T cell dysfunction is a critical feature in this population and will impact clinical outcomes profoundly. This study prospectively researched the predictive value of T cell dysfunction for all-cause mortality and clinical complication in hemodialysis (HD) patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* aged 18 years and older\n* had been on hemodialysis treatment for at least 6 months in our blood purification center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* had been on hemodialysis treatment for at least 6 months in Blood Purification Center,Zhongshan Hospital, Fudan University\n\nExclusion Criteria:\n\n* underwent any kind of cardiovascular or infection event in three months\n* with hematological diseases, rheumatic diseases, active malignancies\n* with history of human immunodeficiency virus infection\n* currently use of any immunosuppressants\n* not followed-up at Zhongshan Hospital, Fudan University'}, 'identificationModule': {'nctId': 'NCT04658069', 'briefTitle': 'T Cell Dysfunction in ESRD', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'T Cell Dysfunction in End-stage Renal Disease', 'orgStudyIdInfo': {'id': 'TcdiESRD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'One Cohort receiving routine hemodialysis therapy without any specific interventions', 'description': 'all HD patients enrolled in this study', 'interventionNames': ['Other: no specific interventions']}], 'interventions': [{'name': 'no specific interventions', 'type': 'OTHER', 'description': 'no specific interventions', 'armGroupLabels': ['One Cohort receiving routine hemodialysis therapy without any specific interventions']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bo Shen, MD', 'role': 'CONTACT', 'email': 'shen.bo@zs-hospital.sh.cn', 'phone': '+86 13564608233'}, {'name': 'Fangfang Xiang, MD', 'role': 'CONTACT', 'email': 'xiang.fangfang@zs-hospital.sh.cn', 'phone': '+86 13816209067'}], 'overallOfficials': [{'name': 'Bo Shen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fudan University'}, {'name': 'Fangfang Xiang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}